SR EN ISO 13485:2012

Dispozitive medicale. Sisteme de management al calităţii. Cerinţe pentru scopuri de reglementare

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls, this can be used

326,99 Lei

Status : Anulat
Data aprobării : 31.07.2012
Data anulării : 31.03.2019
Număr de pagini : 87
ICS : 03.100.70 Sisteme de management,11.040.01 Echipament medical în general
Comitet tehnic : 377 - Medicale

Relaţii cu alte standarde: